PlainRecalls
FDA Devices Moderate Class II Ongoing

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Reported: January 11, 2023 Initiated: November 28, 2022 #Z-0906-2023

Product Description

DeRoyal Tonsillectomy Tray, REF 89-10698.01

Reason for Recall

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

Details

Recalling Firm
DeRoyal Industries Inc
Units Affected
320 units
Distribution
Distribution in US states of VA, and SC.
Location
Powell, TN

Frequently Asked Questions

What product was recalled?
DeRoyal Tonsillectomy Tray, REF 89-10698.01. Recalled by DeRoyal Industries Inc. Units affected: 320 units.
Why was this product recalled?
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0906-2023.